Acute Pulmonary Embolism, Cardiovascular Diseases, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
pulmonary embolism, aspiration thrombectomy, PE, catheter directed thrombectomy
Brief summary
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Interventions
DEVICECleaner Pro Thrombectomy System
The Cleaner™ Pro Thrombectomy System ("Cleaner Pro") is a catheter-based aspiration thrombectomy device comprised of a handpiece, an aspiration catheter, a dilator, and an aspiration canister.
Sponsors
Argon Medical Devices
NAMSA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age at the time of consent * Clinical signs, symptoms, and presentation consistent with acute PE * Onset of PE symptoms occurred within 14 days of presentation * Filling defect in at least one main or lobar pulmonary artery evidenced by CTA * RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9
Exclusion criteria
* tPA use within 14 days prior to baseline CTA * Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg * Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion. * History of severe or chronic pulmonary hypertension * FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90% * Hematocrit \<28% * Platelets \<100,000/µL * Serum creatinine \>1.8 mg/dL * INR \>3 * aPTT (or PTT) \>50 seconds on no anticoagulation * History of heparin-induced thrombocytopenia (HIT) * Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding * Recent (within one month) history of active bleeding from a major organ * Absolute contraindication to anticoagulation * Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days * Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months * Cardiovascular or pulmonary surgery within last 7 days * Cancer which requires active chemotherapy * Known serious, uncontrolled sensitivity to radiographic agents * Life expectancy \<90 days, as determined by investigator * Female who is pregnant * Intracardiac thrombus * Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure * Simultaneous participation in another investigational study * Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S * Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio | At 48 hours post-procedure | Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA. |
| Rate of Major Adverse Events (MAEs) | At 48 hours post-procedure | Rate of MAEs within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding, and Device-related Serious Adverse Events which includes clinical deterioration, pulmonary vascular injury, and cardiac injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device-related complications and device-related death | Within 48 hours of the procedure | Rate of device-related complications including major bleeding, clinical deterioration, pulmonary vascular injury, and cardiac injury, and device-related death within 48 hours of the index procedure. |
| Rate of device-related SAEs and all-cause mortality | Within 30 days of procedure | Rate of device-related serious adverse events (SAEs) and death for any cause within 30 days post-procedure. |
| Rate of Symptomatic PE Recurrence | Within 30 days of the procedure | Rate of Symptomatic PE recurrence within 30 days. |
| Volume of blood aspirated | At index procedure | The amount of blood aspirated during the procedure. |
| Use of thrombolytics | Within 48 hours of the procedure | Use of thrombolytics within 48 hours of the procedure. |
| Change in Modified Miller Index | At 48 hours post-procedure | Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. This index score quantifies arterial obstruction in pulmonary embolism. The higher the score, the more perfusion is reduced. |
| Quality of Life assessed via PEmb-QoL | At 30 days post-procedure | Self-assessment of PE-related complaints and daily living limitations (including work and social). The PEmb-QoL measures 6 dimensions, with higher scores being worse. |
| Quality of Life assessed via EQ-5D-5L | At 30 days post-procedure | Self-assessment of activities for daily living. The EQ-5D-5L measures 5 dimensions, with higher scores being worse. |
Countries
United States
Contacts
STUDY_DIRECTORPete J Stibbs, MD
Argon Medical Devices
Outcome results
None listed